Teva Loses Bid vs Amneal Over Inhaler Patent

HIGHLIGHTS:

• Teva Pharmaceuticals, an Israel-based company, lost to Amneal in patenting its branded inhaler over improper listing to the FDA
• The US court ordered Teva to remove its improper listings to the FDA Orange Book
• The Orange Book only allows patents related to drugs’ certification of safety and effectivity, which Teva’s patents do not include

A US court over the weekend rejected an appeal by Israel-based Teva Pharmaceuticals to reverse a decision that would remove patents for its branded inhaler product ProAir HFA from the Food and Drug Administration’s (FDA) Orange Book.

Instead, the US court sided with American company Amneal Pharmaceuticals, which sought to manufacture and sell a generic version of the product to the market.

Previously, Amneal argued that Teva’s patents were incorrectly listed on the FDA’s Orange Book as they were not patented to certify that the drugs have been approved for commercial use.

To be included in the Orange Book, a patent must claim the drug substance or active ingredient, the formulation and composition, and an approved method of use.

Patent improperly listed

According to US District Judge Stanley Chesler, Teva’s patents only covered parts of a “metered inhaler device” and “do not claim or even mention” ProAir HFA.

Amneal added that Teva’s improper patent listing may have been meant to delay generic competition.

Teva discontinued selling ProAir HFA in 2022.

Considering next steps

The latest decision followed a recent advisory from the Federal Trade Commission (FTC), warning pharmaceutical firms against submitting irrelevant patents to the FDA for the purpose of limiting generic competition.

A report by Reuters quoting a spokesperson from Teva said that the company firmly disagrees with the decision and is already considering other steps.

In a statement, FTC director for policy planning Hannah Garden-Monheit hailed the court’s decision, saying that removal of junk patent listing “is critical to ensuring drugmakers can fairly compete to offer generic products at a lower price for consumers.”

“This decision is important not only for lowering asthma inhaler costs, but it also sets the stage for removal of junk listings on a range of other critical medications where junk device listings impede competition,” she said.

Meanwhile, US Circuit Judge Sharon Prost reiterated: “To list a patent in the Orange Book, that patent must, among other things, claim the drug that was approved.”

“And to claim that drug, the patent must claim at least the active ingredient,” she emphasized.